Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 253-057-0 | CAS number: 36483-57-5
Toxicity to reproduction
Administrative data
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- A study on the Reproduction toxicity is required by REACH for dossier of FR-513. At this point we request to waive this investigation. For the following justification: A 28- day oral repeat dose toxicity study in the rat with a 14 day recovery period was conducted including investigation of some important reproduction endpoints (completed 2015). The results showed no systemic toxicity effects and the No Observed Adverse Effect level (NOAEL) was determined as >500 mg/kg/day (highest dose tested). No treatment related changes in sperm count and motility were observed (data are attached in Table 7 and Appendix 8). Vaginal lavages which were taken early morning during the 3 week period from all females, prior to termination of the animals showed no treatment related changes in the oestrus cycle (data are attached as Appendix 8, in 7. X of the IUCLID file). In addition, there were no dose related changes in organ weight of ovaries, seminal vesicles, testis, ureter, uterus, vagina in comparison to control animals. From the generated scientific data it can be concluded that subacute repeated exposure to FR-513, does not seem to induce adverse effect on the fertility nor cause systemic toxicity or affect the reproductive organs.
Data source
Materials and methods
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
